Isolation of Circulating Tumor Cells Using a Novel EMT-Based Capture Method (CTC-EMT)

The primary objective of the preliminary lead-in study is to determine whether circulating tumor cells in patients with metastatic progressive castration-resistant prostate cancer or metastatic progressive breast cancer can be captured using a novel mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based).

The primary objective of each comparative cohort (second stage, prostate cancer) is to compare the non-detection rate of circulating tumor cells between the standard and novel methods.

Study Overview

• Status: Completed
• Conditions: Metastatic Progressive Castration-resistant Prostate Cancer; Metastatic Progressive Breast Cancer
• Intervention / Treatment: Device: Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Prostate cancer patients will be eligible for inclusion in this study only if all of the following criteria apply:

1. Histologically confirmed diagnosis of adenocarcinoma of the prostate. Small cell or neuroendocrine tumors of the prostate are also permitted.
2. Clinical or radiographic evidence of metastatic disease.
3. Castrate levels of testosterone (<50 ng/dl)

4. Evidence of disease progression on or following most recent therapy as evidenced clinically by the treating physician or by either of the following:

   • Two consecutive PSA levels greater than the PSA nadir achieved on ADT, separated by greater than one week
   • Radiographic evidence of disease progression as defined by new bone scan lesions or growth of soft tissue/visceral metastases >1 cm in diameter (2 cm for lymph nodes).
5. Age > 18 years.
6. Ability to understand and the willingness to sign a written informed consent document.

Breast cancer patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply:

1. Histologically confirmed diagnosis of invasive breast cancer.
2. Clinical or radiographic evidence of metastatic disease.
3. Evidence of disease progression on the current or following the most recent therapy, determined either clinically by the treating physician or by radiographic evidence as defined by new bone scan lesions or soft tissue/visceral metastases >1 cm in diameter (2 cm for lymph nodes).
4. Age > 18 years.
5. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

A patient will not be eligible for inclusion in this study if any of the following criteria apply:

1. History of intercurrent or past medical or psychiatric illness that would make participation in a blood drawing protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s).
2. Treatment with an anthracycline or mitoxantrone within 1 week of CTC collection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Metastatic progressive castration-resistant prostate cancer; Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)	Device: Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)
OTHER: Metastatic progressive breast cancer; Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)	Device: Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Feasibility as measured by successfully detecting at least one CTC in at least 2 out of 10 subjects, comparing the non-detection rate over time.	The change in non-detection rate will be measured by comparing samples from Screening, Cycle 3, and Progression (up to 3 years)

Secondary Outcome Measures

Outcome Measure	Time Frame
Comparison of the proportion of patients with no detectable CTCs between capture methods over time	Change will be measured by comparing samples at Screening, Cycle 3, Progression (up to 3 years)
Changes in CTCs (using each method) over time during systemic therapy	Screening, Cycle 3, Progression (up to 3 years)
Change in correlation of CTC enumeration using each method with baseline clinical and pathologic disease characteristics (for example, clinical stage, site of metastatic disease, Gleason sum for CRPC, PSA for CRPC, previous therapies)	Screening, Cycle 3, Progression (up to 3 years)
Median number of CTCs detected by each method over time	Changes will be measured from screening, cycle 3 and progression (up to 3 years)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: United States Department of Defense; Prostate Cancer Foundation; Janssen Diagnostics, LLC

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: December 19, 2013
• First Submitted That Met QC Criteria: December 30, 2013
• First Posted (ESTIMATE): January 1, 2014

Study Record Updates

• Last Update Posted (ACTUAL): December 20, 2018
• Last Update Submitted That Met QC Criteria: December 19, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Neoplastic Cells, Circulating
• Other Study ID Numbers: Pro00032772